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FDA has received reports of sudden decreased or loss of hearing after using the Erectile Dysfunction drugs such as, Viagra, Levitra, and Cialis. Revatio, a Sildenafil product marketed for pulmonary arterial hypertension, is also included in the list. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. So, FDA asked manufacturers to add a precaution about potential hearing loss to the products labeling.

This request is based on 29 post-marketing reports of sudden hearing loss. In most cases, hearing loss involved one ear and occurred within hours to 3 days of the last dose. Hearing loss appears to be persistent in about 2 out of 3 cases. As per FDA request, the labeling for Viagra, Levitra and Cialis was revised to address this new safety information.
FDA is working on revising label for ‘Revatio’ too.

I was reading the ‘Medscape’ medical news few minutes ago, found out this article intresting and latest. According to this news,

Us food and Drug Administration (FDA) warned healthcare professionals yesterday that Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death. This decision was made based on a review of data from 61 postmarketing cases of hyponatremia-related seizures.
Desmopressin nasal Spray is currently marketed as DDAVP, MINIRIN and STIMATE.
According to MedWatch, the FDA’s safety information and adverse event reporting program, Desmopressin tablets may still be used for primary nocturnal enuresis, however, treatment should be interrupted during acute illnesses that can lead to fluid and/or electrolyte imbalance.

There's a huge backlog at the FDA's OGD, which has seen the number of submitted applications increase by 150 percent

According to the FDA, fewer generics are being approved for two reasons:

A shortage of personnel

and the number of faulty applications that generic companies submit.

OGD needs up to 100 more employees over the next three years to eliminate the build up--a move that would cost between $16 million and $19 million a year.

More funding to the Office of Generic Drugs (OGD) seems to be more logical option to improve adminstrative efficiencies.

FDA Announces Revisions to Labels for Cialis, Levitra and Viagra - The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing. [FDA]